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In these days of far-flung supply chains and multiple assembly locations, even small and midsized manufacturers can have difficulty keeping everyone in their organizations on the same page. If a new standard or regulation affects your assembly process, can you be certain everyone gets the message? If an assembly-related defect is reported in the field, can you be sure the mistake isn’t repeated?

The top priority of any manufacturer is to address quality problems whenever and wherever they occur. The CAPA management module captures these problems from multiple sources. “It can be a customer complaint,” says Willett. “It can come from your MES, because of a problem on the shop floor. It may be an issue with incoming parts from a supplier. It may come from a piece of equipment that’s out of spec.”

When a problem is identified, a number of decisions need to be made quickly. Does the production lot need to be contained? Has it already entered the distribution pipeline? Software tracks it down. In the case of a medical device, the software can also generate an electronic report for the Food and Drug Administration.

At that point, managers can think about identifying the root cause of the problem and how to correct it. Say, for example, an operator was using a machine incorrectly because the work instructions were out of date. The CAPA module can trigger a request to update the instructions in the document management module. The “owner” of the document would know to update the instructions and get any necessary approvals.

When the updated instructions are logged into the system, the training and certification module is alerted to ensure that every operator who uses that machine knows the new procedures. This can be as simple has having each operator sign off on the new instructions. “Or, you may want to have the manager confirm that the operators have read it,” says Willett. “Operators may have to go through a checklist or take a small exam. They may even need classroom or online training. ...And because our software can be integrated with other business software, employee records can be automatically updated to reflect that they have completed the training, which they may need for their job certification.”

Perhaps the cause of the problem wasn’t an outdated work instruction, but a machine that was out of specification. The calibration and maintenance module can tell management when the machine was last calibrated or serviced, and it can notify maintenance personnel to make an adjustment or replace a part.

If the problem was faulty parts from a supplier, the supplier quality module gets triggered. “That could impact the rating of the supplier,” says Willett. “You may want to requalify that supplier. You may even want to change suppliers.”

If ISO or FDA certification is necessary, the audit management module can help engineers prepare for audits and deal with their findings. “Auditors will come through with their questions and checklists,” says Willett. “They may find some issues and...make recommendations for improvement. Engineers can use the software to enter their plans for correcting those issues. Some of the auditor’s findings may be so critical that engineers may want to escalate to a CAPA.”

John has been with ASSEMBLY magazine since February 1997. John was formerly with a national medical news magazine, and has written for Pathology Today and the Green Bay Press-Gazette. John holds a B.A. in journalism from Northwestern University, Medill School of Journalism.